Effects of Functional Progressive Strength Training in Children With Spastic Cerebral Palsy

NCT06407869 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0778
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on the effects of Functional Progressive Strength Training (FPST) on children with spastic cerebral palsy, a condition characterized by increased muscle tone that affects movement. Spastic cerebral palsy is one type of cerebral palsy, with others including dyskinetic, which involves involuntary movements, and ataxic, which affects coordination. FPST differs from traditional strength training by incorporating exercises that replicate everyday activities to integrate strength use in daily movements. The study uses an experimental design with participants aged 6-12 years, recruited from specialized centers. They are randomly assigned to either a treatment group receiving FPST or a control group receiving standard care. The study aims to measure improvements in gait and mobility, assessed through various tools like step and stride length, cadence, and gait speed, alongside caregiver reports and direct observations. Statistical analyses will determine the effectiveness of FPST in enhancing motor function and walking capacity in these children.

Conditions

Spastic Cerebral Palsy

Keywords

Spastic CP, Functional Progressive Strength Training

Outcome Measures

Primary Outcomes (1)

• Gait Parameters

  To assess gait parameters in a study, four tools are utilized: step length, measuring the distance between alternating heel strikes; stride length, measuring the distance between two heel strikes of the same extremity; cadence, counting the number of steps taken; and gait speed, timing the duration to cover a 5-meter distance with a stopwatch.

  12 weeks

Secondary Outcomes (1)

• 1-Minute Walk Test

  12 weeks

Study Arms (2)

Functional Progressive Strength Training

EXPERIMENTAL

group of 20 children with spastic cerebral palsy on which FPST techniques including 3 or 4 PRT sessions per week for 12 weekswill be applied.

Other: Functional Progressive Strength Training

Control

OTHER

group of 20 children with spastic cerebral palsy on which conventional physical therapy techniques will be applied

Other: Control

Interventions

Functional Progressive Strength Training OTHER

The Functional Progressive Resistance Exercise (FPRE) protocol is designed to improve functional strength through structured workouts. It begins with a 3-minute warmup involving stretching and range of motion exercises, followed by progressively intense sit-to-stand exercises over six weeks. Participants also perform half-kneeling, standing up, and side-step-up exercises, with 20 minutes of total activity and rest intervals. The session ends with a 2-minute cooldown. Weights are gradually increased up to 15 times the initial load, with a minimum of one-minute rest between sets. The regimen is tailored through trial and error to find the maximum load participants can effectively manage.

Functional Progressive Strength Training

Control OTHER

conventional physical therapy techniques will be applied

Control

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6 to 12 years
• Children had to be able to understand and follow instructions
• Diplegic CP
• GMFSC I, II, III

You may not qualify if:

• Treatment with botulinum toxin A in lower limb.
• Rhizotomy done 6 months before the study.
• Children with unstable seizures will be excluded.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Hanssen B, Peeters N, De Beukelaer N, Vannerom A, Peeters L, Molenaers G, Van Campenhout A, Deschepper E, Van den Broeck C, Desloovere K. Progressive resistance training for children with cerebral palsy: A randomized controlled trial evaluating the effects on muscle strength and morphology. Front Physiol. 2022 Oct 4;13:911162. doi: 10.3389/fphys.2022.911162. eCollection 2022.

  PMID: 36267577 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kashaf Naeem, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask both groups about treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It will be randomized control trial in which random sampling technique will be used. Two groups of 6-12 age will be formed in which participants will randomly be divided. Group A will receive Functional Progressive Resistance Exercises and group B will receive conventional stretching and strengthening exercises

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: June 28, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 25, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)